Replies to post #124935 on Biotech Values

[read_this_n0w]

INSM clinical hold update on mondays company CC.

"We continue to expect that we will be able to supply the currently requested information and data to FDA before the end of August. Importantly, the Agency has advised us that it will respond to Insmed within a 30-day period following the receipt of our complete response to their request noted in their correspondence. Of course, we will not be screening and enrolling patients into our clinical trials until we receive feedback from FDA and the clinical hold is lifted.

"

Full CC text

Text of CEO's August 8th CC.


This is the text of Tim Whitten - Insmed Incorporated - President & CEO during the August 2011 CC:

Thank you, Brian. Hello, everyone, and thanks for joining us today. I would like to begin the call by addressing what I am sure is top-of-mind for all of you.

Last week we announced that the FDA placed a clinical hold on Insmed's Phase III clinical trials for Arikace, a liposomal formulation of amikacin for inhalation in cystic fibrosis patients with Pseudomonas lung infections and patients with nontuberculous mycobacteria lung disease. As we previously stated, we were informed by FDA that their decision was based on an initial review of the interim results of a long-term rat inhalation carcinogenicity study that Insmed recently received and submitted to the Agency.

As it relates to the clinical hold, I would first like to emphasize that we continue to believe Arikace has the potential to be an important treatment option for cystic fibrosis patients who have Pseudomonas lung infections and non-TB mycobacteria lung infections, or NTM, based on the efficacy and safety data generated from the Phase II clinical trial program. Our Phase II placebo-controlled clinical trial results for cystic fibrosis, or CF, patients who have Pseudomonas lung infections have shown statistically significant improvement in lung function during the 28-day treatment period which was sustained in the off-treatment period.

In addition, the Arikace open label study demonstrated that Arikace delivered once daily for 28 consecutive days followed by 56 days off treatment for a total of six cycles resulted in statistically significant improvement in lung function that was sustained both on and off treatment over a 72-week period. So based on the human clinical efficacy and safety data generated to date for Arikace, we remain excited over its prospects in CF patients who have Pseudomonas lung infections. And with regard to NTM, there remains a high unmet need with few good treatment options, and we believe that Arikace has the potential to play an important role in treating these patients as well.

Now I turn to some of the details on the two-year rat inhalation carcinogenicity study. I believe this background and history provide important context in evaluating where we are currently with Arikace and FDA. In addition, I will briefly discuss the impact this clinical hold might have on our Phase III clinical programs for Arikace in CF patients who have Pseudomonas lung infections and non-TB mycobacteria, or NTM, lung infections.

First, some background on the carcinogenicity study. For many new chemical entities carcinogenicity studies are also often required to be filed as part of a new drug application or NDA. This was the case for Arikace.

In our discussions with the Agency regarding our NDA submission requirements, FDA indicated that the Company would be required to conduct a two-year rat inhalation carcinogenicity study and include the final report as part of a potential Arikace new drug application. This carcinogenicity study was not a requirement for entering Phase III clinical trials.

We previously conducted multiple non-clinical toxicology studies in animals. I point this out because there seems to have been some confusion around why a study in rats would not have taken place much earlier in Arikace's development cycle. In fact, the results from three-month and six-month toxicology studies in animals were submitted and reviewed by FDA at much earlier points in time. But while many companies do not initiate the required carcinogenicity program until after they have begun the Phase III clinical trials, we were actually ahead of the curve on timing for our long-term carcinogenicity study.

We contracted with a qualified external laboratory to do the two-year rat inhalation carcinogenicity study. That company conducted the data, they generated the data, and they -- that company conducted the study, they generated the data, and provided the results. More specifically, dosing for the study began in March 2009 and ended in March 2011 with the animals receiving daily dosing during that two-year time period.

Following completion of dosing, the evaluation of data could begin. In carcinogenicity studies, because of their size and the large body of data that needs to be evaluated, results are usually not known for many months. As a result, the interim data was provided to the Company only recently.

The Company determined that there were findings in the interim data that should be reported to FDA, and we did this. Following FDA's review of this submission, the Agency provided us with verbal notification of the clinical hold on the Phase III clinical programs for Arikace in CF and NTM. Based on the verbal communication from the Agency, we issued the August 1 press release that indicated the Arikace Phase III clinical trials for both CF and NTM were placed on clinical hold.

We also notified the clinical trial sites, institutional review boards, and the principal trial investigators of the clinical hold expeditiously. Subsequently, on August 3, we received written notification from the Agency that confirmed and was consistent with an earlier verbal communication.

After reviewing the data, we believe we have a sound scientific rationale for the findings and look forward to working closely with our experts and with the FDA to provide the Agency with all relevant information and data required to expedite their review and evaluation.

We continue to expect that we will be able to supply the currently requested information and data to FDA before the end of August. Importantly, the Agency has advised us that it will respond to Insmed within a 30-day period following the receipt of our complete response to their request noted in their correspondence. Of course, we will not be screening and enrolling patients into our clinical trials until we receive feedback from FDA and the clinical hold is lifted.

As far as the implications of the clinical hold for Insmed and the Phase III Arikace clinical trials, we have the infrastructure and clinical trial networks in place to quickly resume our clinical trial program if we are allowed to do so. Depending upon the timing of the FDA's review and response, we are hopeful that we can resume our Phase III clinical trial program for Arikace during the fourth quarter of 2011.

In terms of our cash position, whether we can progress Arikace to approval in CF or NTM with our current cash will depend upon the timing of FDA's review and response, the subsequent timing of the start of our Phase III clinical trials, and the rate of patient accrual for those trials. We will continue to assess this as we move forward with FDA.

While the recent clinical hold announcement has negatively impacted our stock valuation, we believe we have taken -- we believe we are taking the appropriate steps with FDA to address the findings from the interim results of our long-term rat inhalation carcinogenicity study that led to the clinical hold. We believe we have a sound scientific rationale for those findings and expect to respond to FDA's request for more information before the end of August. The Agency has advised us that it will respond to Insmed within a 30-day period following receipt of our complete response to the request noted in their correspondence.

In closing, I reiterate that our goal is to resume the Phase III clinical trial program for Arikace as soon as possible. With that I will turn the call over to Kevin for his review of the financials. Kevin?

Link for more:
http://investor.insmed.com/secfiling.cfm?filingID=1104506-11-36

[Zardiw]

And the plants are infertile .....have to buy seeds every year from Monsanto......z

[biomaven0]

FWIW, this NY Times article from May claims the USDA isn't too impressed:

The market could be vast. In North America, up to 40 percent of crop-loss insurance claims are due to heavy or moderate drought, according to some estimates. Worldwide, corn-growing regions lose about 15 percent of their annual crop to drought, and losses run much higher in severe conditions.

However, Monsanto's corn is unlikely to perform well enough to tap this potential, USDA found.

While the agency's draft environmental assessment of the modified corn found the crop unlikely to pose a plant pest risk, prompting USDA to seek deregulation, the agency also noted that many corn varieties on the market match Monsanto's strain in their water use.

"The reduced yield [trait] does not exceed the natural variation observed in regionally-adapted varieties of conventional corn," the report says, adding that "Equally comparable varieties produced through conventional breeding techniques are readily available in irrigated corn production regions."

Given the slight improvements made by the corn, the agency does not project that approving the variety would cause an increase in corn cultivation. Last year, U.S. farmers planted some 86.4 million acres of corn, 86 percent of which was genetically engineered to grant resistance to insects and weedkillers.

http://www.nytimes.com/gwire/2011/05/11/11greenwire-usda-looks-to-approve-monsantos-drought-tolera-84634.html

Any significant advance in drought-tolerance will I think have a dramatic impact on world food supplies, but if the USDA quotation is correct here then it doesn't sound like they are there yet.

Peter